FDA.reportPublic FDA data

NDC 45802-998 - clindamycin and benzoyl peroxide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
45802-998
Package NDCs from labels
45802-998-03
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2022-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
clindamycin and benzoyl peroxide - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2022-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-998-03clindamycin and benzoyl peroxide27.6 g in 1 BOTTLE, PUMPGEL27.6 g50 mg in 1g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-998CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Unmatched20231011_6bf0f3e5-6ad7-4791-9483-0977b18ad77f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 41 of 43 · 844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEZydus Pharmaceuticals USA Inc.83d52507-99a1-4461-b067-5ec01dc6c5d32022-10-05Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd221de6a3-c1d7-4dcf-a47b-51edaa682c2a2022-10-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEMayne Pharma Inc.56541736-c70e-4fcd-9614-6cfdc50441362022-08-31Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd92dcba02-f42f-482d-8cd5-2b5ab8fa540a2022-06-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDETeva Pharmaceuticals, Inc.05babd5f-18ab-4646-8962-cb000ed0f9a82022-05-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltd2e6f96d0-d928-4775-a7db-3e998fce675b2022-04-06Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
CLINDAMYCIN AND BENZOYL PEROXIDECLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9cba4e83-64b0-43b6-a337-cd0fd4744d312022-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA202440
rxcui: 358917
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd1144d82f-085c-45a4-b32d-9b24c495d1542022-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA202440
rxcui: 358917
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd6bf0f3e5-6ad7-4791-9483-0977b18ad77f2022-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA202440
ndc (package): 45802-510-03
ndc (package): 45802-998-03
ndc (package): 45802-738-03
ndc (product): 45802-510
rxcui: 358917
spl id: 84f65326-838e-412d-a5b4-44a28cea1415
spl set id: 6bf0f3e5-6ad7-4791-9483-0977b18ad77f
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltdf5e0ce64-605d-487c-a7b9-c00457925d942022-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA202440
rxcui: 358917
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.